Ambrx Biopharma Inc. and Quantum Leap Healthcare Collaborative™ Announce the Inclusion of ARX788 in the I-SPY 2.2 Phase 2 Adaptive Clinical Trial for Breast Cancer

Excerpt from the Press Release:

Quantum Leap Healthcare Collaborative™ (Quantum Leap) and Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the selection of Ambrx’s antibody drug conjugate (ADC) ARX788 for a new investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting. Sponsored by Quantum Leap, the I-SPY 2.2 TRIAL is a continuation of the I-SPY 2 TRIAL that seeks to create personalized treatments by adapting therapies for each patient to optimize the clinical outcom

“We are particularly excited about this collaboration,” stated Dr. Laura J. Esserman, MD, MBA, Director of the Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center, and Principal Investigator of I-SPY Family of Trials. “We hope this will usher in an era of more targeted, effective and less toxic therapies for people with HER 2 positive breast cancers, leveraging decades of investment in science and drug development, and delivering better treatment to patients when they need it most. This is the right drug, for the right patient at the right time.”

I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. ARX788 will be evaluated as a monotherapy, and in combination with the PD-1 targeting checkpoint inhibitor cemiplimab, in HER2-positive early-stage breast cancer in the neoadjuvant setting. Ambrx anticipates the ARX788 arms to begin enrolling patients in May 2022.

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